Epidemiological Study in Thai Participants With Hypertension

NCT ID: NCT02467855

Last Updated: 2015-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2071 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult participants with essential hypertension.

Detailed Description

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This study has been designed as a non-interventional, observational study to obtain information on hypertension treatment regimens and how well hypertension is controlled in Thai patients in real-life settings. Antihypertensive medications prescribed in this study will be at the discretion of the investigator and the standard of care practice at the particular study site.

The study will enroll approximately 2000 patients. Participants with well-controlled hypertension on their current antihypertensive therapy will participate in the study for only 1 visit. Participants with history of hypertension who are uncontrolled on the current antihypertensive medications or participants with newly diagnosed hypertension (diagnosed within the past 4 weeks and uncontrolled on antihypertensive therapy) will be observed over the course of 12-16 weeks. These participants will make 3 visits to the study site.

This multi-centre trial will be conducted in Thailand.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cross-Sectional Cohort

Participants receiving standard of care for hypertension with well-controlled hypertension will participate in 1 visit.

No Intervention

Intervention Type OTHER

No intervention was administered in this study.

Longitudinal Cohort

Participants receiving standard of care for hypertension with history of hypertension who are uncontrolled on the current antihypertensive medications or participants with newly diagnosed hypertension (diagnosed within the past 4 weeks and uncontrolled on antihypertensive therapy) will be observed over the course of 12-16 weeks.

No Intervention

Intervention Type OTHER

No intervention was administered in this study.

Interventions

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No Intervention

No intervention was administered in this study.

Intervention Type OTHER

Other Intervention Names

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No intervention was administered in this study.

Eligibility Criteria

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Inclusion Criteria

1. Ability to provide written informed consent
2. Age above 18 years.
3. Participants with essential hypertension as per European Society of Hypertension/European Society of Cardiology (ESH/ESC) criteria in general, target blood pressure (BP), systolic blood pressure (SBP) \<140 and diastolic blood pressure (DBP) \<90 mmHg, in diabetes, target BP, SBP \<140 and DBP \<85 mmHg, in renal disease with overt proteinuria (urine albumin excretion \> 300 mg/day or 200 microgram/min), target BP, SBP \<130 and DBP \<90 mmHg).

Essential Hypertension will be defined based on the criteria established by the ESH/ESC 2013 criteria:

* Grade 1 Essential hypertension - Systolic blood pressure (SBP) 140 - 159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg with no identifiable cause
* Grade 2 Essential hypertension - SBP 160 - 179 mmHg and/or DBP 100 - 109 mmHg with no identifiable cause
* Grade 3 Essential hypertension-SBP ≥ 180 and/or DBP ≥ 110 mmHg with no identifiable cause.

Exclusion Criteria

1. Female participants who are breastfeeding or pregnant or who are intending to become pregnant.
2. Has known or suspected secondary hypertension.
3. Is currently enrolled in or has not yet completed at least 30 days since ending an investigational product or device study or is receiving other investigational agents.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

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Pathumwan, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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AZI-P4-003

Identifier Type: -

Identifier Source: org_study_id

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